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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH CLICKX LOCKCAP T25 TAN; ORTHOSIS, SPINAL PEDICLEFIXATION, FOR DDD
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OBERDORF SYNTHES PRODUKTIONS GMBH CLICKX LOCKCAP T25 TAN; ORTHOSIS, SPINAL PEDICLEFIXATION, FOR DDD Back to Search Results
Catalog Number 04.606.000
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Failure of Implant (1924); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/ investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/ or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that two (2) locking caps were released which resulted in the displacement of the titanium bar.The two (2) locking caps were changed to stabilize the patient.Concomitant devices: unknown rods (part # unknown, lot # unknown, quantity # unknown), unknown screws (part # unknown, lot # unknown, quantity # 14), unknown transverse connector (part # unknown, lot # unknown, quantity # unknown).This report is for one (1) clickx lockcap t25 tan.This is report 2 of 4 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: part: 04.606.000, lot: 4l31943, manufacturing site: mezzovico, release to warehouse date: 08.Apr.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Customer quality investigation: the complaint device was not received for investigation.The following investigation is based on the image(s) provided.The image(s) were reviewed, and the complaint condition could not be confirmed, there were no displacement of the locking caps and screws noticed.Since the device was not returned, a dimensional inspection and a functional test were not able to be performed.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.A definitive assignable root cause could not be determined based on the provided information.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
CLICKX LOCKCAP T25 TAN
Type of Device
ORTHOSIS, SPINAL PEDICLEFIXATION, FOR DDD
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9659146
MDR Text Key190649330
Report Number8030965-2020-00793
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07611819937345
UDI-Public(01)07611819937345
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number04.606.000
Device Lot Number4L31943
Was Device Available for Evaluation? No
Date Manufacturer Received02/19/2020
Patient Sequence Number1
Treatment
UNK - RODS; UNK - SCREWS; UNK - TRANSVERSE CONNECTOR
Patient Outcome(s) Required Intervention;
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